510(k) Report

FDA applicant

Long First (Xiamen) Co., Ltd.

Kaohsiung, TW3 decisions1999–20030 recalls

FDA records 3 decisions for Long First (Xiamen) Co., Ltd. (Kaohsiung, TW) from 1999 to 2003: 3 510(k) clearances. All are in product code LYZ (Vinyl Patient Examination Glove). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Long First (Xiamen) Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Long First (Xiamen) Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Long First (Xiamen) Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Long First (Xiamen) Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Long”

FDA records each applicant name separately; these may or may not be the same firm.